Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

NCT ID: NCT05702996

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-09-30

Brief Summary

The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.

Conditions

Thrombotic Microangiopathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient with Thrombotic microangiopathies induced by gemcitabine

Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab

Group Type: EXPERIMENTAL

Eculizumab administration

Intervention Type: DRUG

Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab

Interventions

Eculizumab administration

Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Age ≥ 18 years old 2. Previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams). 3. Neoplasia in remission or not in remission but with an estimated life expectancy > 6 months 4. Acute renal failure defined by 1 of the following 2 criteria : Creatinine > 2 times baseline creatinine and/or diuresis < 0.5 ml/kg/h for 12 hours. 5. Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system, 6. Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form. 7. Woman of childbearing age with effective contraception as defined by the WHO (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -HCG pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or Postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or For men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment

Exclusion Criteria

• 1. Progressive neoplasia with a life expectancy of <6 months 2. Patient with a contraindication to the administration of the treatment experienced: SOLIRIS® 300 mg concentrate for solution for infusion 3. Contraindication to antibiotic prophylaxis 4. Thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation) 5. Active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy) 6. Unresolved meningococcal infection 7. Patient not vaccinated against meningococcal infection 8. Pregnant or breastfeeding woman or proven lack of contraception 9. Known systemic lupus erythematosus 10. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship 11. Patient participating in another interventional clinical trial / having participated in another interventional clinical trial within 1 month

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven GRANGE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Amiens University Hospital

Amiens, , France

Rouen University Hospital

Rouen, , France

Countries

France

Central Contacts

Steven GRANGE, MD

Role: CONTACT

steven.grange@chu-rouen.fr

+3323288 ext. 8261

Florian VALLIN

Role: CONTACT

florian.vallin@chu-rouen.fr

+3323288 ext. 8265

Facility Contacts

Claire PRESNE, MD

Role: primary

Steven GRANGE, MD

Role: primary

Other Identifiers

2020/0206/HP

Identifier Type: -

Identifier Source: org_study_id